Job Title: Senior Quality Engineer, QMS

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Join our Quality Operations team at Framingham Biologics facilities! We support CAPAs, Deviations, Change Controls, supplier quality, document control, and more. Our mission is to ensure all Quality Systems activities meet regulations and drive continuous improvements.

As a key user of the CAPA, Deviation, and Investigation (CDI) QMS, you'll oversee system health, be the quality approver for records for this system, identify improvement opportunities, and lead implementations.

• Collaborate with various departments to review and approve complex Change Control (CCR) and CDI records.
  
• Represent the Quality System team in policy discussions.
  
• Attend GEMBA on the production floor to assess deviations, impact, and root cause analysis.
  
• Provides compliance expertise on the floor.
  
• Ensure compliance with corporate requirements within the QMS
  
• Provide regular metrics, trend reports, and system health assessments.
  
• Lead and mentor peers and contribute to continuous improvement initiatives.
  
• Decision Making: Challenges include responsible for high complexity decision making related to Quality or Compliance and ensuring that risks or deviation from decisions made by the Quality representative are escalated to QA Operations Management, QA Director or the Quality Site Head as needed to ensure Safety, Identity, Strength, Purity, Quality (SISPQ) of product.
  

• Basic: Bachelors in science/engineering with a minimum of 6 years in cGMP, or Master's with 4+ years. Experience in Quality Engineering/Assurance/Control and knowledge of cGXP regulations and biologics or similar manufacturing processes.
  
• Preferred: Self-motivated, organized, excellent communicator, detail-oriented, strong interpersonal and project management skills, and proficient in electronic document systems such as Trackwise and/or Veeva, Excel, Word, PowerPoint, and databases.
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.